BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2070704 · Received April 14, 2011

    Report

    Report Number
    2531779-2011-02456
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGES WERE NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGES WERE NOT RETURNED, THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PT STATED THAT INSULIN LEAKED FROM HIS CARTRIDGES TWO WEEKS PRIOR TO CALLING ANIMAS. HE SAYS HE NO LONGER HAS THE CARTRIDGES BUT BELIEVES INSULIN LEAKED TWO WEEKS AGO AT THE PLUNGER. HE DISCOVERED THE ISSUE SOON AFTER INSERTING THE CARTRIDGES INTO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN CARTRIDGE LZG ANIMAS CORP. IR 1200 / 1250 / 2020 / OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR